1. Field of Invention
The present invention relates generally to the field of orthotic devices and appliances; more particularly to orthotic devices and appliances in combination with electrotherapy useful for restoring movement to a connective joint of a mammalian body; and still more particularly to orthotic devices and appliances in combination with electrotherapy used to reverse contractures due to immobility and neurological dysfunction.
2. Background Discussion
Webster""s New Collegiate Dictionary defines xe2x80x9corthoticsxe2x80x9d as xe2x80x9ca branch of mechanical and medical science that deals with the support and bracing of weak or ineffective joints or muscles.xe2x80x9d
Orthotic devices and appliances, commonly referred to just as xe2x80x9corthoticsxe2x80x9d(in spite of the broader dictionary definition of orthotics) have been utilized for many years by physical therapists, occupational therapists, and certified orthotic fitters to assist in the rehabilitation of loss of range of motion (LROM) of patients joints and associated limbs or adjacent skeletal parts of the patients"" body.
Orthotics, as well as splints, have been designed both to maintain and to restore the range of bodily motion due to LROM. Such loss of range of motion may, for example, be caused by traumatic injury, rehabilitation following joint or limb surgery, and contracture due to immobilization caused by neuromuscular disorders (e.g., stroke and closed head injury) and other disease processes that significantly limit a patients ability to use a joint for normal activities of daily living (ADL).
Two fundamentally different types of contractures exist which clinically should have two different treatment protocols. The difference in these two types of contractures is the basis for the clinical techniques and design of the orthotics of the present invention which will be described below.
A first one of these two fundamentally different types of contracture may be defined as a fixed, high resistance of muscle to passive stretch resulting from fibrosis of the muscles and joints, or from disorders of the muscle fiber resulting in LROM, for example, of a patient""s arm or leg. In this regard, Webster""s Dictionary defines xe2x80x9ccontracturexe2x80x9d as xe2x80x9ca permanent shortening (as of muscle, tendon and scar tissue) producing deformity or distortion.xe2x80x9d
This first type of contracture is usually due to trauma, injury, or surgical intervention affecting the joint, as may be typical of sports injuries and the treatment thereof. As the injured tissue heals, edema, post trauma or surgically affected tissue regeneration and other natural healing processes result in fusing together of what were, prior to the trauma, separate, pristine connective tissues, that is, the collagen fiber matrix (depicted diagrammatically in FIG. 1A hereof), capable of easily gliding over one another, as is needed for normal joint movement and related muscle elongation.
However, post-trauma, this collagen fiber matrix becomes random and irregular (depicted diagrammatically in FIG. 1B hereof), and neither elongates nor stretches compared to non-traumatized collagen fibers. This fusing together or adhesion of connective tissue structures (e.g., ligaments, tendons, synovial membrane, fascia and fibrous joint capsules) is the result of the tissues being invaded by developing undifferentiated scar between adjacent tissue, thereby diminishing or preventing the mutual gliding after early healing of the trauma or post-surgical trauma has been accomplished.
Such fusing together of connective tissue is a leading cause of lags (a non-specific indictment of the motor system""s failure to move the affected joint through the full available passive range) relating to tendon gliding, depending on their strategic placement in reference to structures crossing the joint. With limited mobility and associated extensor muscle atrophy, combined with the formation of adhesions and scar tissue in the form of a significantly increased number of joined fiber matrix junctions, the muscle fibers become shortened.
The restoration of full range of motion where fibrosis of the muscle fiber with scar tissue and adhesions are present, requires that the adhesions and scar tissue or fused fiber matrix junctions be xe2x80x9cworked throughxe2x80x9d or broken to restore normal functional elongation or stretch. The term xe2x80x9cno pain, no gainxe2x80x9d (of increased ROM) is associated with the process of breaking through joined or fused fiber matrix junctions to restore full elongation of the connective tissue, tendons and muscles associated with the trauma-affected joint.
Heretofore known orthotics are primarily designed to treat this first type of contracture, but have also been used to treat contractures caused by immobility and neurological dysfunction (described below). However, such orthotic devices are not, as far as is known by the present inventor, best suited for such additional purpose.
The second and very different type of contracture results from joint immobilityxe2x80x94not joint-related trauma or surgical repair of a joint. Contracture resulting from immobility is simply a shortening and thickening of the connective tissue, tendons and muscles (depicted in FIG. 1C hereof) that restrict the ROM of a joint. In such situations, the muscle fibers still retain their original uniform shape and there are no adhesions or scar tissue or significantly increased joined fiber matrix junctions to break through in order to restore full range of motion.
In contrast to trauma-caused contractures, contractures due to immobility do not need a xe2x80x9cno pain, no gainxe2x80x9d approach to restoring the normal range of motion, and, in fact, such an approach can actually do more harm than good. As mentioned above, the collagen fibers of a contracture due to immobility are simply shorter and thicker, and will respond to appropriate stretching techniques and motion of the joint to restore LROM. The stretching technique usually used for contractures caused by immobility is Range Of Motion (ROM) Therapy and the use of Low-Load Protracted Stretch/Stress (LLPS) or xe2x80x9cextended stretchxe2x80x9d static or dynamic orthotic devices.
According to authors Kenneth R. Flowers and Susan L. Michlovitz in their article titled xe2x80x9cASSESSMENT AND MANAGEMENT OF LOSS OF MOTION IN ORTHOPEDIC DYSFUNCTIONxe2x80x9d (published in Postgraduate Advances in PHYSICAL THERAPY, American Physical Therapy Association, 1988 II-VIII), Total End Range Time (TERT) in conjunction with LLPS is the key to restoring full ROM.
All contractures, whether caused by injury, surgery, or immobility, limit range of motion of the affected joint and make simple activities of daily living, such as eating and self-dressing, more difficult, if not impossible. Moderate to severe contractures can be debilitating, and can leave afflicted individuals bed-bound and unable to care for themselves in the most basic daily living tasks. Even mild contractures due to immobility can progress to severe contractures if proper intervention is not prescribed and implemented so long as the immobility continues.
Electrotherapy has been used extensively in the rehabilitation of joint and muscle related injury, pain, and LROM. Electrotherapy also has demonstrated other valuable healing properties. Many forms of electrotherapy exist, and are characterized by the wave form of the electrical current. The wave form xe2x80x9cratexe2x80x9d or frequency refers to the number of pulses delivered per second. Pulse rate is the number of pulses in each energy wave. Pulse width is the length of time each energy burst stays on (for example, double pulse width to double the energy in that pulse). Pulse amplitude or height of the pulse increases as the amplitude setting is increased. The total energy per pulse is determined by the amplitude and pulse width. Many variations of electrotherapy wave forms exist that are utilized therapeutically for joint rehabilitation, pain management, and the healing properties provided by electrical stimulation.
The use of transcultaneous electric neuromuscular stimulation or TENS has been used extensively to treat muscle injury and related pain. TENS is characterized by biphasic electric current and selected parameters. TENS has clinically demonstrated the ability to increase blood flow, reduce swelling and edema, and provide both acute and chronic pain relief. TENS is commonly used to treat back and cervical muscular and disc syndromes, arthritis, shoulder syndromes, neuropathies and many other conditions. Neuromuscular electrical stimulation or NMES also provides many therapeutic benefits. NMES is characterized by a low volt stimulation targeted at motor nerves to cause a muscle contraction. Electrically controlled contraction/relaxation of muscles has been found to effectively treat a variety of musculoskeletal and vascular conditions. It is used to maintain or increase range of motion, prevent or retard disuse atrophy, muscle re-education, relaxation of muscle spasm, increase circulation, and for deep vein thrombosis prevention.
Microcurrent therapy is characterized by a subsensory current that acts on the body""s naturally occurring electrical impulses to decrease pain and facilitate the healing process. Such form of electrotherapy provides symptomatic pain relief for both post surgical and post traumatic acute pain. Interferntial therapy or IF is characterized- by the crossing of two medium, independent frequencies which work together to effectively stimulate large impulse fibers. These frequencies interfere with the transmission of pain message at the spinal chord level. Because of these frequencies, the IF wave meets low impedance when crossing the skin to underlying tissue. This deep tissue penetration can be adjusted to stimulate parasympathetic nerve fibers for increased blood flow and edema reduction. High Voltage Galvanic Therapy is characterized by high volt, pulsed galvanic stimulation, and used primarily for local edema reduction through muscle pumping and through xe2x80x9cpolarity effectxe2x80x9d. This type of electrotherapy is used to increase or maintain range of motion, to treat disuse atrophy, for muscle re-education, to increase circulation, and to treat degenerative joint disease.
Different electrotherapy wave forms, for example, as described above, have been identified for the treatment of varying conditions. Some of the benefits are perceptible to the user (felt during therapy) and others are below the perception level. The specific electric pulse width and pulse rate can be controlled and varied, and as a result can have a wide range of clinical benefits. Electrotherapy can elicit very significant muscle contraction of specific muscles to entire muscle groups. On the opposite end of the spectrum, electrotherapy can be used to inhibit muscle contraction and even provide total nerve block therapy simply by directing the correct electrical wave form to the appropriate site to have the desired clinical effect. Electrotherapy has also been used to keep neurotransmitters in the muscles functioning normally until new neuropathways can be developed to reconnect the muscle groups to the brain post stroke, spinal cord injury, closed head injury, etc.
Electrotherapy has also been used to provide soft tissue therapy, and has been used extensively for the repair of nerves, tendons and ligaments as well as muscles. IF and electro-therapeutic applications have been used to treat contractures, re-connect damaged neuro-pathways, heal chronic wounds, and to treat incontinence. The U.S. Public Health Department in it""s pamphlet on The Treatment of Pressure Sores cited electrotherapy has having the greatest clinical promise of providing possible treatment breakthroughs in the treatment of chronic wounds.
Electrotherapy is applied primarily through the use of an electrotherapy unit (device emitting a controlled electrical wave form and amplitude) through electrical connections to strategically placed electrodes placed on the body to provide electrical current to the desired site.
A principal objective of my current invention is accordingly to provide more clinically effective orthotics that are an alternative to the known types of orthotics currently used to treat contractures caused by immobility and the ROM stretching technique. The main function of my new and more effective orthotic devices is to treat contracture due to immobilityxe2x80x94not trauma related to surgery or injury.
The present inventor considers that TERT with Activity Stimulus strategy (i.e., flexing)xe2x80x94not LLPS-is the key to predisposing tissue to elongation and restoring range of motion, where LROM is due to immobility or neurological dysfunction.
The clinical importance and value of my invention are significant in that contractures and other hazards of immobility are one of the ten current highest health care costs in America that are totally preventable. This puts the health risks associated with immobility in the same category as cigarette smoking, alcohol and drug abuse, and automobile accidents in financial impact on American health care costs.
The new orthotic devices of the present invention provide more effective clinical treatment for LROM due to immobility by increasing the xe2x80x9cstimulus of activityxe2x80x9d of the affected tissue (connective and muscle fiber) rather than just holding the issue in moderately lengthened position (LLPS or xe2x80x9cgradual extensionxe2x80x9d therapy). According to Brand (1984), xe2x80x9cIt is better not to use the word stretch for what should be long-term growth. If we want to restore normal length to a tissue that has shortened after disease (or disuse), we need to reverse the process and apply the stimulus of activity, or better, the stimulus of holding the tissue in the moderately lengthened position for a significant time.xe2x80x9d According to Brand, it will then xe2x80x9cgrowxe2x80x9d or lengthen. Flowers and Michovitz in the before-mentioned article theorize that the joint somehow senses or computes the total stress applied to it in any given direction over a period of time. It then stimulates a proportionate amount of biological activity, leading to a proportionate mount of remodeling of the stressed tissue. The total stress is a product of its intensity, frequency and duration. The crucial elements in this conceptual model are frequency and duration. Total stress equals intensity times frequency times duration (intensityxc3x97frequencyxc3x97duration).
The present orthotic devices increase the stimulus of activity relative to current orthotic devices which simply hold the limb and joint in an extended position for extended periods. Conceptually, patient outcomes should be more positive based upon an increased stimulus of activity as well as providing moderate stretch for a prolonged period with the new devices. The cycling or repeated extension and contraction of the joint by the new devices provides the additional benefits of motion (activity), increased lubrication of the tissues (production of synovial fluid) facilitating movement, and muscle re-education and diminished spasticity where neurological dysfunction is present (stroke, closed head injury, MS, etc.). The level of activity is higher with the new devices when high tone, spasticity, or moderate to high contraction reflexes are present in the affected limb and joint. Thus the new devices are uniquely appropriate for contractures due to immobility where neurological dysfunction is present in the affected limb.
In accordance with the present invention, there are provided orthotic devices, for example, in combination with electrotherapy, useful for extending the range of angular movement between adjacent first and second skeletal body parts which have been drawn to and involuntarily held in a shortened or restricted angular position (limited to a narrow range of motion) relative to one another by contraction of muscles and connective tissue due to immobility. Each such orthotic device comprises a first orthotic device portion, a second orthotic device portion, and means interconnecting the first and second orthotic device portions for permitting relative angular motion therebetween. Included are means for establishing an initial angle between the first and second orthotic device portions.
Further comprising the orthotic device are means for operatively applying or connecting the first orthotic device portion to the first body part and the second orthotic device portion to the second body part after the first body part has been pivoted, by an externally applied force, to an increased angular position relative to the first body part, the first and second orthotic device portions being then set by the establishing means at the initial angular position relative to one another which corresponds to the increased angular position of the second body part relative to the first body part.
Spring means are connected between the first and second orthotic device portions for urging the second orthotic device portion to return to its initial angular position relative to the first orthotic device portion when the second orthotic device portion is pulled by the applied first body part through muscular contraction and/or the elastic properties of the muscles and connective tissue from the increased angular position toward the second angular position of the first body part relative to the first body part, thereby pulling the second body part back toward the increased angular position relative to the first body part.
The spring means are configured so that pivotal movement of the second orthotic device portion relative to the first orthotic device portion away from the increased angular position causes a restoring loading of the spring means. This restoring loading of the spring means and the muscular contraction and/or the elastic properties of the muscles and connective tissue of the firsts body part act against one another and cause the second body part to cycle angularly toward and away from the first angular position and the increased angular position without further external intervention, thereby causing a gradual angular loosening of the second body part relative to the first body part and ultimately positioning the second body part at the increased angular position without the application of other forces.
The spring means are further configured for providing substantially no or a low load spring force between the first and second orthotic device portions when the second orthotic device portion is at the initial angular position relative to the first orthotic device portion.
In one embodiment of the invention, the first body part comprises the individual""s upper limb part and wherein the-second body part comprises the individual""s lower limb part, the limb being the individual""s arm or leg.
In such case, the first orthotic device portion includes a first cuff and the second orthotic device portion includes a second cuff. The applying means releasably attaches the first cuff to the lower limb part and releasably attaches the second cuff to the individual""s upper limb part.
The interconnecting means comprise at least one stiff member having a first end region fixed to the first cuff and a second end region fixed to the second cuff and including a hinge intermediate the first and second end regions for enabling relative angular movement therebetween in a plane defined by the longitudinal axis of the limb upper and lower parts.
Means are included for releasably locking the hinge at any selected angular position of the first end region relative to the second end region. The hinge may also or alternatively include a ratchet for enabling the opening of the first end region relative to the second end region from one angle therebetween to a larger angle therebetween.
Preferably, the spring means comprise relative outwardly bowing and twisting of the first and second end regions of the member when the second end region of the bar is pivoted from the initial angular position relative to the first end region to a smaller angle therebetween.
In a variation orthotic device, the orthotic device of the present invention comprises a thermal setting, flexible member having first and second regions defined by a bend line between the first and second member regions, a bend at the bend line being set by heating, bending and cooling the member at the bend line, the bend line permitting angular movement and enabling the setting of a selected angle between the first and second member regions.
Means are included applying or attaching the first member region to the first body part and the second orthotic device portion to the second body part after the second body part has been moved against contracture forces away from the LROM position to an initial extended range of motion (ROM) angular position relative to the first body part, the first and second member regions being then set at the initial extended range of motion position relative to one another.
Also includes are spring means associated with the second and second member regions for urging the first member region to return to the extended ROM position in response to the second member region being pulled by the applied or attached first body part through muscle fiber contraction and/or the elastic properties of the muscle fibers and connective tissue away from the extended ROM position and toward said LROM position, thereby causing a cycling movement of the second body part between said extended ROM and LROM angular positions and a gradual loosening of the second body part relative to the first body, part and an ultimate extending of the ROM of the second body part relative to the first body part at the extended ROM position without additional external intervention.
The spring means are configured for providing substantially no or a low load spring force between the first and second orthotic device portions when the second orthotic device portion is at the initial extended ROM angular position relative to the first member region.
In one version, the first body part comprises the individual""s forearm at the wrist and the second body part comprises said individual""s hand. In another version, the first body part comprises the individual""s lower leg at the ankle and the second body part comprises said individual""s foot.
In another version, the first body part comprises the individual""s back at the neck and the second body part comprises the individual""s head. In another version, the first body part comprises an upper region the individual""s back and the second body part comprises a lower region of the individual""s back.
In still another version, the first body part comprises an individual""s upper thigh after lower regions of the leg have been amputated and the second body part comprises a lower region of the individual""s torso at the hip.
In yet another version, the body part comprises the individual""s forearm at the wrist and the second body part comprises said individual""s hand.
In the orthotic device for each of the pairs of body parts it is preferred that the spring means are provided by flexibility of the elastic member.
In a particularly useful embodiment, the present invention is directed systems comprising orthotic devices, for example, such as those described herein, and electrode components positioned to be effective to conduct an electrical current to at least one body part of a patient being treated. The orthotic device preferably is adapted to extend the range of angular movement between adjacent first and second skeletal body parts which have been drawn to and involuntarily held in a limited angular range of motion position relative to one another by contraction of muscle fibers and connective tissue due to immobility of one or both of said skeletal body parts. The electrode components preferably include a plurality of individual electrically conductive elements or electrodes strategically placed relative to the orthotic device, for example, in or on the orthotic device, to combine orthotic treatment and electrotherapy. A power source, for example, an electrotherapy unit, such as those of conventional design, disposable units and the like, is used to provide electrical power or energy to the electrode component so that electrical current can be provided to the desired body part or parts. Although the orthotic device may be worn by the patient for several hours, the electrotherapy may be actually used for either all or a portion of the time the orthotic is worn.
The combination of electrotherapy and an orthotic device has many advantages over the separate use of each modality. The electrotherapy can be activated through the strategic placement of a plurality of conductive elements or electrodes, for example, in or on the orthotic device to provide numerous therapeutic benefits. Electrotherapy can elicit partial to total muscle inhibition to allow the orthotic device to provide superior muscle stretch and to eliminate the pain and discomfort sometimes experienced by the wearing of an orthotic device. Muscle strengthening and reeducation, muscle contraction inhibition, increased blood flow, nerve stimulation and neuro-pathway reconstruction, and other benefits can also be provided while the patient wears the orthotic device. By combining the application and therapeutic benefits of both modalities in one device, therapeutic patient outcomes as well as patient compliance are often significantly increased. The electrotherapy/orthotic therapy combination preferably reduces the treatment time required relative to the treatment time required if each therapy is provided separately.
Many advantages are evident in the combination of the two modalities. A few of the benefits include:
1) inhibiting contraction of the contracted muscles, tendons, and connective tissue to allow the orthotic device to provide xe2x80x9clong effectsxe2x80x9d or permanent stretch therapy for a greater period relative to using only one of the modalities;
(2) muscle strengthening and re-education of the xe2x80x9cantagonistxe2x80x9d muscles to provide longer lasting permanent stretch and joint range of motion. By strengthening the antagonist muscle group opposing the xe2x80x9cshortenedxe2x80x9d or contracted muscle group, the xe2x80x9ceffectxe2x80x9d of the contracted muscles is diminished and the muscles are maintained in a stretched permanent position;
(3) by enhancing the development of new neuro-pathways to the brain so that muscle groups non-responsive to brain function can be significantly improved, providing greater post stroke or other neurological disorder rehabilitation, resulting in an improved use of the effected side;
(4) increasing blood flow, reducing swelling, and enhancing the production of synovial fluid will enhance joint movement.
(5) providing muscle contraction inhibition and/or nerve block electrotherapy with the ability of the orthotic device to provide Low Load Prolonged Stretch (LLPS) conveniently allows maintaining an optimal setting of the orthotic device. The orthotic device setting is effectively self adjusted, for example, by a ratchet-like hinge, to the gains made via the electrotherapy portion of combined therapy device. Thus, numerous device checks or modifications become unnecessary; and
(6) The combination of electrotherapy with orthotic stretch requires significantly less therapy or caregiver intervention to enhance therapy.
There are other potential benefits to having an electrotherapy component built into the orthotic device. The list of benefits cited is not meant to be exhaustive, only to provide insight as to the benefit of the present invention to the field of contracture management. The soft goods and/or hard goods of the present orthotic device can be configured appropriately to provide the desired therapeutic result.